Evaluation of Safety and Efficacy of NvisionVLE® Imaging Low Profile System in Patients With Bile Duct Disease

NCT05263752 | Completed FDA Device

• 1 other identifier: 059.GID.2017.D
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

A previous study evaluating the NvisionVLE® Imaging Low Profile System revealed the system to be feasible and safe for use in bile duct. The study also revealed a potential to better define abnormalities, target sampling and therapy when utilizing the NvisionVLE® Imaging Low Profile System. This study will further evaluate the safety and efficacy of the NvisionVLE® Imaging Low Profile System in patients with bile duct diseases.

Conditions

Bile Duct Diseases

Outcome Measures

Primary Outcomes (6)

• Demographics- DOB

  Date of birth

  up to 2 years

• Demographics- Sex

  Male/Female

  up to 2 years

• Indication of Procedure

  Anatomy Used: Biliary or Pancreatic

  up to 2 years

• Previous Surgical History

  Stent type and Location

  up to 2 years

• Previous Imaging

  Type of Imaging: CT or MRI for example

  up to 2 years

• Previous Procedures

  EUS or ERCP

  up to 2 years

Study Arms (1)

Undergone ERCP with NvisionVLE® Imaging Low Profile System

Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019

Device: ERCP with NvisionVLE® Imaging Low Profile System

Interventions

ERCP with NvisionVLE® Imaging Low Profile System DEVICE

Endoscopic Retrograde Cholangio-Pancreatography (ERCP) with NvisionVLE® Imaging Low Profile System

Undergone ERCP with NvisionVLE® Imaging Low Profile System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of patients over the age of 18 years who are scheduled to undergo an ERCP with Nvision VLE Imaging Low Profile System.

You may qualify if:

• Age 18 years or older
• Undergone ERCP with NvisionVLE® Imaging Low Profile System at MDMC between 10/15/2017 and 10/15/2019.

You may not qualify if:

• Below 18 years of age
• Did not undergo ERCP with NvisionVLE® Imaging Low Profile System at MDMC

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Health System

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Bile Duct Diseases

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Prashant Kedia, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: March 3, 2022
• Study Start: October 18, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: March 23, 2026

Record last verified: 2022-02

Locations

US (1)